Monday, January 28, 2008

FDA To Require Suicide Studies in Drug Trials

From the New York Times:

The FDA is now requiring drug makers to study closely whether patients become suicidal during clinical trials. Rules

The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.

Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials.